Annals of International Medical and Dental Research - Volume 5, Issue 6, November- December 2019

ISSN (0):2395-2822; ISSN (P):2395-2814

A Comparative Study Between Intravenous Ketorolac and
Intravenous Paracetamol to Alleviate Post-Intubation
Sore Throat

Shree Nanda’, Jyoshna Mishra’, Hari Krishna Dalai?
1Associate Professor, Department of Anaesthesia, MKCG, Medical College, Berhampur.
Assistant Professor, Department of Anaesthesia, MKCG, Medical College, Berhampur.
3Professor, Department of Anaesthesia, SLN, Medical College, Kerapnt.

Received: September 2019
Accepted: September 2019

Copyright: © the author(s), publisher. It is an open-access article distributed under the terms of the Creative
Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and
reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Background: Context: Complains of pain in throat have been recorded in patients subjected to intubation of the
trachea to such an extent as requiring analgesic interventions.In the modern multi-modal analgesia approach,
non-opioid and NSAID group of drugs are in vogue to provide perioperative analgesia. Ketorolac and Paracetamol
are two such drugs employed to treat surgical pain. Aim: To study and compare the effectivity of Ketorolac and
Paracetamol in decreasing throat pain following endotracheal intubation. Settings and design: Prospective
randomised parallel assigned single blind control study. Methods: Conducted on 120 consenting adult patients
who required endotracheal intubation for surgery.They were divided into 3 groups of 40 patients each-C,K and
P.Group K patients were premedicated with IV Inj.Ketorolac and Group P patients with IV_ Inj.Paracetamol
10minutes before induction of anaesthesia.Group C patients were the Control group.All patients were administered
standard identical general anaesthetics .After recovery from anaesthesia, the incidences and severity of pain in
throat was assessed and graded.The observations were tabulated and statistically analysed. Statistical analysis
used: OpenEpi online software. Results: Both Ketorolac and Paracetamol decreased incidences and severity of
throat pain. Ketorolac premedication provided better results than Paracetamol. Conclusion: Intravenous Ketorolac and
Paracetamol both lessen sore throat caused by tracheal intubation.

Keywords: Ketorolac, Paracetamol, Post operative Sore throat.
Key messages: Premedication with intravenous Ketorolac or Paracetamol, alleviates post-operative sore throat.

INTRODUCTION

been described as the eighth most undesirable
postoperative experience of patients by Macario et

Every medical intervention, while helping the
patient to recover, leaves behind some
unforeseen, undesirable tell-tale after-effects.
Endotracheal intubation is the most __ relied
method used to secure airway in anaesthetised
patients and trauma victims. Patients nursed in
Intensive Care Units require prolonged intubation
for respiratory support. Complains of sore throat,
hoarse voice and cough have been documented in
these patients two to six hours following
tracheal extubation."*! The incidences being
reported as 14% by McHardy and Chung to
80% by some other observers.'**! Postoperative
sore throat has also been cited asa cause of
delayed discharge, longer hospital stays. It has

lame & Address of Corresponding Author
Dr. Jyoshna Mishra,
Flat No-301,
Nandighosh Ashiyana,

Ayodhya Nagar, Berhampur,
Gandam,
Odisha.

al.37]

To alleviate this unpleasant sequelae, apart from
minimal airway handling, intubation only after
complete relaxation of vocal cords with
endotracheal tubes that are smaller in size and have
high-volume-low-pressure cuffs; or intubating with
spiral-embedded or micro-cuffed tubes have been
employed. So also pharmacological interventions
like applying jellies of Lignocaine/Cinchocaine,
K-Y jelly or Betamethasone gel on the surface of
the endotracheal tube before intubation; gargling
with warm saline, or solutions of Lignocaine,
Ketamine, Benzidamine hydrochloride, Azulene
sulfonate or Aspirin before intubation or after
extubation; sucking lozenges of local anaesthetic
(Amethocaine); and inhaling Fluticasone or steam
or Beclomethasone, etc have been prescribed to
provide relieve from this disagreeable irritating
sensation. But all these have shown mixed
results.7:!°!51 Search is still on for a better remedial
procedure.

Canals of Intemational Medicat and Dental Research, Vel (5), Josue (6) Pagel

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Nanda et al; Post-Intubation Seve Shieat

Paracetamol and Ketorolac are two non-opioid
analgesic agents that have now gained wide
acceptance for postsurgical pain relief."*+!®! Keeping
in mind that pain (soreness) in throat was the
complaint received from the suffering patients,
the aim of this study was to evaluate and
compare the efficacy of ‘Ketorolac’ and
‘Paracetamol’ in preventing Post-Operative Sore
Throat (POST) when administered intravenously

as a premedicant in patients requiring
endotracheal intubation for surgery.
MATERIALS AND METHODS

This was a prospective parallel assigned single blind
random study. Our primary goal was to observe
for incidences of sorethroat and assess their
severity. The secondary aim was to check the
effect on duration of postsurgical analgesia and
also to note any untoward side effects.
Permission from the ethics committee of our
institution was taken. Patients were explained
about the nature of the study. Their written
consent was obtained. Between the years 2014 and
2016, One hundred and twenty patients posted for
elective surgery under general anaesthesia
needing endotracheal intubation were randomly
selected and divided into three groups of forty
each. Both male and female patients between the
ages eighteen to sixty years, having average body
built and belonging to ASA grades I and II were
enrolled in this study. Following patients were
excluded from this study:

Patients refusing to be part of the study,

Patients having respiratory tract infection,
Bronchial asthma, Acid peptic disease, hepatic, renal
or cardiac disorders,

History of allergy to NSAID group of drugs,
Patients anticipated to pose difficulty in intubation.

Twelve sealed opaque envelopes, four of which
contained cards labeled K, four with cards
labeled P and rest four having cards labeled C
inside were prepared, mixed and kept inside a box.
After selection of the patients, an investigator who
was not part of drug administration nor data
collection or analysis randomly picked and opened
one of these envelopes and assigned the patients
accordingly to one of the three groups named K, P or
C. Each group consisted of forty subjects. The
study drugs were administered by the OT
pharmacist, being not involved in the data
collection and analysis. As the Inj.Paracetamol
infusion is supplied in hundred ml infusion bottles,
hence it was only possible to have a single blind
study. Here the patient was blinded to the study
drug being administered.

Group K - received Inj.Ketorolac(30mg ) LV. ten
minutes before induction of anaesthesia.

Group P- received Inj.Paracetamol(1gm) LV. ten
minutes before induction of anaesthesia.

Group C - were studied as the control group and
received neither Inj.Ketorolac nor Inj.Paracetamol.
All the patients were administered IV
Inj.Glycopyrrolate(0.2mg), Inj. Midazolam (0.05
mg/kg), Inj.Pentazocin (0.5mg/kg), Inj. Ranitidine
(50mg). Anaesthesia was induced with intravenous
Inj.Propofol(2mg/kg). Trachea was intubated with
appropriate size oro-tracheal tubes under direct
laryngoscopic vision, facilitated by intravenous
Inj. Vecuronium bromide(0.1mg/kg). Cuff of the
tube was inflated with air. After confirmation of
appropriate placement, the tube was _ fixed.
Anaesthesia was maintained with Nitrous Oxide :
Oxygen (60:40), Isoflurane(0.4%) and intermittent
incremental doses of intravenous Inj.Vecuronium
with controlled ventilation. At the end of surgery,
all anaesthetics were withdrawn. Residual
neuromuscular paralysis was reversed with Inj.
Neostigmine (0.05mg/kg) and Inj. Glycopyrrolate
(0.1mg/kg). We used _high-volume-low- pressure
single-use type Portex endotracheal tubes. The
tubes were not lubricated. No local anaesthetic
was applied over the endotracheal tubes or on
laryngo-tracheal mucosa. Pressure inside the cuff
was maintained between 20 — 25 cm H20. Heart
Rate, Non-invasive Blood Pressure, ECG and
SpO2 were continuously monitored.

The incidence and severity of ‘sore throat’ in
the post-operative period (POST) were recorded
and graded at 0, 2,4 & 24 hours following
recovery from anaesthesia by using the following
Verbal Rating Scale:

Grade 0 = No Pain

Grade I = Mild/Slight Pain

Grade II= Moderate Pain

Grade III = Severe Pain

Grade IV = Very Severe Pain.

Patients requiring more than 2 attempts at
intubation were excluded from _ this _ study.
Following recovery from anaesthesia,
Inj.Diclofenac(75mg) was administered IM as
rescue analgesic when the patients complained
of pain or VAS of pain was more than 3.

RESULTS

Observations
The following parameters were observed:-

. Incidences and severity of Postoperative sore

throat,

. Perioperative haemodynamic changes,
. Duration of postoperative analgesia,
. Side-effects if any.

The data obtained was tabulated. Statistical analysis
for significance was done applying OpenEpi
software. Qualitative analysis was done using
Chi square test. ANOVA test was done for
quantitative analysis of the data. P<0.01 was
considered to be significant.

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The incidences and severity of sore throat were
studied as the primary outcomes. of _ this
investigation and duration of postoperative
analgesia as the secondary outcome. The following
are the data obtained in this study:-

Table 1: Comparison Of Demographic Variables

(N=40) | (N=40) | (N=40)

0 HOUR 25 10 15 0.002
(62.5%) | (25.0%) | (37.5%)

2 HOUR 20 8(20.0 | 10 0.008
(50.0%) | %) (25.0%)

6 HOUR 15 25.0%) | 6 0.0007
(37.5 %) (15.0%)

24 HOURS 8(200 | 1(25%) | 4 0.041
%) (10.0%)

(Mean + SD)
Parameters Group- | Group- | Group- | P-
Cc K P Value
(N=40) (N=40) (N=40)
AGE (In 38.104 36.7 + 37.95 +4 0.553
Years) 7.87 8.64 9.38
BODY 52.60 + 54.85 + S7.A5+ 0.085
WEIGHT (In 11.90 8.54 5.69
Kg)
Male / Female 24/16 26/14 22/18 0.0659
Asa Grade 32/8 28/12 30/10 0.586
(I/II)
Mean
duration of 121.254 137.75 124.75+ | 0.016
surgery (in 24.57 + 25.67 29.53
minutes)

The demographic data observed among 3 groups
were comparable without any significant statistical
difference.

Table 2: Incidences Of Postoperative Sore Throat (Chi
Square Test using 3x2 table)

Time Of Group — | Group— | Group-— | P-
Observation Cc K P Value

P<0.01- was considered to be significant

In Group-K and Group-P incidences of POST at 0
hr, 2 hr, 6 hr were significantly less in comparison
to control group.

In Group-C, at the end of surgery(0 hr), out of 40
patients, 62.5% complained sore

Thro at in comparison to 25% in Group-K and
37.5% in Group-P.

At 2hr, 50% patients complained sore throat in
Group-C , 20% in Group-K, 25% in Group-P.

At 6hr, in Group-C incidence of POST was 37.5%;
5% in Group-K and 15% in Group-P.

At 24hr, in Group-C 20% had POST in comparison
to 2.5% in Group-K and 10% in Group-P.

In this study we observed that, IV Inj.Ketorolac
and Inj.Paracetamol significantly decreased the
incidence of POST by the end of Ohr, 2hr and 6hr
in comparison to control group.

Table 3: Severity Of Postoperative Sore Throat.

Grade of 0 Hour 2 Hour 6 Hour 24 Hour

Severity Cc K P Cc K P Cc K P Cc K P
Grade 0 0 0 0 0 0 0 0 0 0 0 0 0
Grade I(Mild) 10 8 9 12 5 7 8 1 4 3 1 3
Grade II 13 2, 6 5 3 3 5 1 2 4 0 1
(Moderate)

Grade III 2 0 0 3 0 0 2 0 0 1 0 0
(Severe)

Grade IV 0 0 0 0 0 0 0 0 0 0 0 0
(Very Severe)

Total 25 10 15 20 8 10 15 2 6 8 1 4
Group C:

Out of 40 patients, 62.5% developed POST at 0
hour. Of these 40% had mild, 52% moderate and
8% experienced severe degree of sore throat at the
end of the surgery.

After 2 hours, 50% patients had POST, of which
60% were mild, 25% moderate and 15% severe in
nature.

After 6 hours, 37.5% of patients developed POST,
of which 53.3% were of mild, 33.3% moderate and
13.3 % of severe degree.

After 24 hours, out of 40 studied patients, 20% had
POST. Of these, 37.5% had mild, 50% moderate
and 12.5% severe sore throat.

Gradual decrease in percentage of POST in control
group was due to administration of rescue
analgesia(Inj.Diclofenac 75 mg) when patients
complained of pain.

In Ketorolac_Group (K):
At 0 hour, only 25% of studied patients suffered

from POST; of which 80% were mild, 20%
moderate, while no patient complained of severe
pain.

At the end of 2 hours, out of the 20% patients who
developed POST, 62.5% were mild, 37.5% moderate
in nature and none had severe form.

After 6 hours, only 5% had POST, of which 50%
had mild and 50% had moderate form.

At 24 hours, only | patient (2.5%) had POST, and it
was mild in nature.

None of the patients of Group-K developed severe
form of POST & a smaller number of patients
complained of sore throat in comparison to control

group.

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Nanda et al; Past-Intubation Save Shieat

In Paracetamol Group (P):
From 40 patients studied, 37.5% developed POST

at the end of surgery; of which 60% were mild and
40% of moderate severity while none suffered of
severe type.

After 2 hours, 25% patients complained of POST, of
which 70% were of mild degree and 30% moderate,
while no patient developed severe form.

At 6 hours, of the 15% patients who developed
POST, 66.6% suffered of mild and 33.3% from
moderate sore throat.

When examined after 24 hours, only 10% patients
suffered from POST. Of these, 75% were mild
and 25% were of moderate severity.

Incidence and severity of POST was also less in
Group-P in comparison to control group.

Table 4: Total Duration Of Postoperative Analgesia

(Mean + SD)

Time for Group C Group K Group P
requirement of | (n=40) (n=40) (n=40)
Rescue 2.95 + 0.83 6.85 + 1.63 5.67 + 1.57
analgesia (in

Hours)

By using ANOVA test, the P-value calculated was
0.0001 (Highly Significant) Time for requirement of
rescue analgesia in Group-K and Group-P was later
in comparison to control group. Duration of
analgesia was more in Group-K in comparison to
Group-P. Thus, decrease in postoperative analgesic
demand was an added advantage of Ketorolac and
Paracetamol premedication.

Table 5: Perioperative Cardiovascular Variables
(Mean + SD)

CVS Group Group Group p-

Parameters C K P value
(n=40) (n=40) (n=40)

Pulse Rate 88.15 + 85.70 + 89.05 + 0.075

(in Minutes) 5.40 9.03 5.07

Systolic Blood | 123.40+ 120.70 + 121.00+ | 0.113

Pressure ii 7.98 TAS

(mmHg)

Diastolic 78.30 + 7810+ 7540+ 0.088

Blood Pressure | 7.26 6.20 5.98

(mmHg)

P-value was calculated by using ANOVA test. No
Statistically significant difference was observed in
the cardiovascular parameters among the three

groups.

Table 6: Incidences Of Side Effects Of Studied Drugs

Group C Group K Group P
(n=40) (n=40) (n=40)
Nausea 0 2 0
Vomiting 0 0 0
Others 0 0 0

Two (2) patients In Group-K complained of nausea.
No other side effects were observed in all the three
groups in this study.

DISCUSSION

In the year 2012 Maria Jaensson etal analysed
the factors responsible for female patients
developing sore throat following endotracheal
intubation."! They observed that age above 60
years, use of larger sized endotracheal tubes,
application of throat packs were significant
contributors to development of pain in throat.
Incidentally, their analysis also showed _ that,
intracuff pressure less than 20cm water was
associated with development of postoperative
hoarseness of voice. J Saleem and S Athar in
an article published in Critical Care in 2008
reported that incidences of POST occured more
with PVC than Armoured endotracheal tubes.!*!
Trauma to the larngo-pharyngeal mucosa and
submucosal structures caused by the endotracheal
tubes and other aids to intubation have been
attributed as factors for development of POST.4,20
McHardy and Chung have reported _ that
laryngoscopy and endotracheal intubation injures the
laryngeal and tracheal mucosa leading to oedema
and haematoma of the vocal cords. They have also
reported formations of ulcers and granulomas of the
cord structures in patients subjected to tracheal
intubation.“! Trauma, ulcers, granulomas — all
produce tissue inflammation of which pain is a
predominant presenting feature. NSAID group of
drugs are gaining grounds in the modern trend of
multimodal approach to _ peri-operative pain
management. Ketorolac tromethamine is said to be
very effective in reducing postsurgical tissue
inflammation and pain.”!*3! On the other hand,
intravenous Paracetamol, is also being increasingly
employed as a pre-emptive analgesic agent for
effective management of acute surgical pain.!'*!¢
So we analysed the effectiveness of these two
drugs in diminishing the symptoms of POST.

This study was conducted on surgical procedures
lasting in average 1.5 hours to 2.5 hours. We
noted significantly less incidences of sore throat
in patients premedicated with IV Ketorolac and
Paracetamol in comparison to control group of
patients at 0 hour, 2 hours and 6 hours following
tracheal extubation. After 24 hours, though
comparatively more number of patients © still
suffered from POST, but it was statistically not
significant.

Upon analyzing the severity of throat pain, we
noticed that in patients who had __ received
Ketorolac and Paracetamol, the pain was mostly
mild in nature at all points of times. Some
patients did suffer from moderate pain in these
two groups, but they were observed to be
comparatively less. None of the patients given
Ketorolac or Paracetamol suffered from either
severe or very severe degree of POST. While in
the control group, although soreness was of mild

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Nanda et al; Past-Intubation Seve Shieat

degree in greater number of cases at different
times of observations; we marked that, in this
group, comparatively more patients suffered from
moderate pain immediately after extubation.
Though none of the patients in control group
had very severe POST, however, significant
percentage of patients described the pain as
severe type. The gradual decrease in incidents
and severity of POST that happened in control
group in later periods of time can be explained
as due to the effect of rescue analgesic
Inj.Diclofenac.

In comparison to the control group, the duration
of postoperative analgesia was greatly increased
in patients who had received Ketorolac or
Paracetamol, the p-value being highly significant.
Ketorolac provided longer postsurgical pain
control in comparison to Paracetamol.

Ketorolac and Paracetamol premedication did not
produce any _ significant effect on the
cardiovascular system in our study. While two(2)
patients in the Ketorolac group complained
ofnausea, we did not observe any other notable
side effects of the studied drugs in our current
series of patients.

In two independent studies of prevention of
POST where a control group was compared
with IV Ketorolac and the other compared a
control group with IV Paracetamol, it had been
observed that in patients premedicated with
either of these compounds, there was decrease in
incidences and severity of POST and _ patients
had prolonged duration of postoperative
analgesia.745]

CONCLUSION

Premedication with Inj.Ketorolac or Inj.Paracetamol
decreases the incidences, intensity and severity of
sore throat following tracheal intubation as well as
decreases the demand for postoperative analgesia.
Intravenous Inj. Ketorolac gives better results when
compared to intravenous Inj.Paracetamol. This might
be due to its anti-inflammatory effect.

Limitations

Small sample size.

Efffect of throat pack not studied.

Effect on patients on prolonged intubation needs to
be observed.

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24. Nanda S, Dalai HK, Mishra J. Intravenous Ketorolac
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How to cite this article: Nanda S, Mishra J, Dalai HK. A
Comparative Study Between Intravenous Ketorolac and
Intravenous Paracetamol to Alleviate Post-Intubation Sore

Throat. Ann. Int. Med. Den. Res. 2019; 5(6):ANO1-ANO6.

Source of Support: Nil, Conflict of Interest: None declared

Annals of Intenaticnal Medical and Dental Research, Vel (5), Josue (6) Page 6